MSD's Investigational Anti-PD-1 Antibody, Pembrolizumab, Under Regulatory Review in Europe for the Treatment of Advanced Melanoma

MSD's Investigational Anti-PD-1 Antibody, Pembrolizumab, Under Regulatory Review in Europe for the Treatment of Advanced Melanoma

MSD, known as Merck (NYSE:MRK) in the United States and Canada, today announced the European Medicines Agency (EMA) has accepted for review a Marketing Authorization Application (MAA) for pembrolizumab (MK-3475), the company's investigational anti-PD-1 antibody, for the treatment of advanced melanoma. If approved by the European Commission (EC), pembrolizumab has the potential to be the first anti-PD-1 therapy in Europe. Additional regulatory filings in other countries outside of Europe are planned by the end of 2014.

"With the five-year survival rate for patients with advanced melanoma at less than 20 percent, there remains a need to offer patients additional options," said Dr. Roy Baynes, senior vice president, clinical development, Merck Research Laboratories. "We are pleased to have regulatory applications under review in the United States and Europe as we work toward bringing pembrolizumab to patients around the world."

About Advanced Melanoma

Melanoma is the most serious form of skin cancer and is the 19(th) most common cause of cancer death in Europe. In 2012, there were an estimated 22,200 deaths from malignant melanoma in Europe. There were an estimated 232,000 new cases of melanoma diagnosed worldwide in 2012.

About Pembrolizumab

Pembrolizumab (MK-3475) is an investigational, selective, humanized, monoclonal anti-PD-1 antibody designed to reactivate anti-tumor immunity. Pembrolizumab exerts dual ligand blockade of the PD-1 pathway by inhibiting the interaction of PD-1 on T cells with its ligands PD-L1 and PD-L2.

Today, pembrolizumab is being evaluated across more than 30 types of cancers, as monotherapy and in combination. It is anticipated that by the end of 2014, the pembrolizumab development program will grow to more than 24 clinical trials, enrolling an estimated 6,000 patients at nearly 300 clinical trial sites worldwide. For information about Merck's oncology clinical studies, please visit http://www.merck.com/clinical-trials/index.html.

The Biologics License Application (BLA) for pembrolizumab is under priority review with the U.S. Food and Drug Administration (FDA) for the treatment of patients with advanced melanoma previously-treated with ipilimumab; the PDUFA date is October 28, 2014. Pembrolizumab has been granted FDA's Breakthrough Therapy designation for advanced melanoma. If approved by the FDA, pembrolizumab has the potential to be the first anti-PD-1 therapy approved within the United States.

About MSD Oncology

At MSD Oncology, our goal is to translate breakthrough science into biomedical innovations to help people with cancer worldwide. Harnessing immune mechanisms to fight cancer is the priority focus of our oncology research and development program. The Company is advancing a pipeline of immunotherapy candidates and combination regimens. Cancer is one of the world's most urgent unmet medical needs. Helping to empower people to fight cancer is our passion. For information about MSD's commitment to Oncology visit the Oncology Information Center

 

One stop shop for healthcare information, medical research now online

One stop shop for healthcare information, medical research now online

Medical students and doctors in India can access healthcare information, including research articles from multiple reputed medical journals, courtesy an online initiative by Merck Sharp & Dohme (MSD).

Explaining how the medical initiative ‘Univadis’ was different from the explosion of information already available on the Internet, MSD Managing Director KG Ananthakrishnan told Business Line that the portal had tie-ups with different independent medical journals, including the Lancet and BMJ, providing them all to medical professionals under one roof. And in the case of Lancet, some research articles would even be available a week ahead of the published version.

This is not a marketing tool, Ananthakrishnan said, adding that the company does not promote any of its products through the portal. The medical fraternity can access a host of things from the entire text of some Lancet research papers to tools such as medical calculators to three-dimensional images, among other things, on the site. Besides, it can be customised to individual requirements.

Swashraya Shah, MSD Senior Director (Medical Affairs), said doctors in the country were estimated to spend about 54 per cent of their browsing time looking for authentic medical information from reputed institutions. It is available in over 40 countries, including China and Russia, where it launched in the last couple of years, he said, adding that localised content would follow, but at a later date.

Outlining Lancet’s involvement with the portal, David Collingridge, Lancet Oncology’s Editor-in-Chief, said the Lancet articles on the portal were filtered and selected by their own editors. So not only do medical professionals gain access to different publications in one place, they also get research articles filtered and hand-picked by Lancet editors.

Responding to how the medical journal keeps an arms-length from MSD in the online initiative, Collingridge said independence was key and there was no bias from the company in the selection of articles. There are strong firewalls, he said, adding that they would not have got on board if it wasn’t the case.

For a campaign journal like Lancet, it was important that their voice be heard in more regions. Through the portal and its recent foray into China, India and Russia, Lancet gets to address the largest demographic for healthcare reform, he said.

In fact, says Anjan Sen, MSD Senior Director (Strategy and Commerical Operations), in countries such as Greece, Brazil and China, the Government was in partnership with the initiative, especially when it came to continuing medical education.

 

Novartis steps up innovation with key focus on oncology

Novartis steps up innovation with key focus on oncology

Swiss drug major Novartis has an enviable drug pipeline in the world, one of the largest for anti-cancer drugs which is the company’s key focus area. The company, which brought the famous blood cancer drug Glivec to the world, spoke about its next breakthroughs, in a conference at its headquarters in Basel. CNBC-TV18's Archana Shukla shares the key highlights. The key takeaway was that the company is looking at a unique approach of using single target for multiple indications, one drug that can treat multiple indications. Also Read: FDA approves Ranbaxy's generic version of Novartis's Diovan The company has about 18 drugs in the late stage developmental pipeline but the focus purely is on oncology. So, for oncology they alone have about 27 drugs both in the early as well as late stage pipeline and the company is also boosted by the recent acquisition of GSKs oncology portfolio which has added molecules for Breast Cancer as well as Myeloma which were missing from Novartis's earlier portfolio. There are two-three key drugs on which the company is betting big, which includes Tasigna, a second generation Glivec to treat Blood Cancer. This also treats patients who have become resisting to Glivec. The company is also doing trials to take it one step further and see if these drugs can be stopped once the cancer goes undetected. It will be a breakthrough in cancer treatment if these trials are promising and the drug goes through because till now cancer patients take drugs life long. If this happens then they would get rid of taking medicines life long once their tumor goes undetected. Those trials in the second stage would also come to India but the dates of that are yet to be finalised. The other targeted therapy for cancer which the company is betting big on is the CART therapy which converts the patients own B-cells to target tumors. They are in the stages of clinical trials and are hoping to file in the US in 2016. There are two other drugs to treat heart failure where the company is very confident. There is no treatment available in the world to treat heart failures, also an indication which is prominent in India with rising incidences of heart failure. The company has two drugs in the late stages pipeline that it is really confident of making through. It has also started fresh trials for those drugs in Asia and India ( Novartis India  ) is a lead contributor in clinical trials for those drugs and would also be one of the countries where they will bring it first. Soaring costs of drug discovery was another key highlight of discussion. Novartis’ global head of development pointed out that costs have soared as much as USD 4 billion per drug. That is the cost of developing one single drug and the reason why patented drugs have become so expensive and the companies are very reluctant to bring down prices is because as part of the innovator driven companies they also need to recover the costs that they have spent on developing that drug. This is a global phenomena, not only with Novartis but all innovation driven companies that are facing high costs, companies like Merk, Bayer, J&J all of them are facing a similar situation. However, they are also working on strategies to look at reducing costs somehow, maybe by using newer technologies or looking at weeding out weaker molecules earlier in the pipeline so that they do not spend a lot of money developing them and fail later.. The other way the management said to look at is in innovating pricing strategies like outcome based pricing strategy which is being discussed in the European nations where one discusses with the payer and the government to decide on a price based on the outcome of the drug, outcome of how well it treats the patient. That could be a way forward even for countries like India to look at pricing especially at a time when the government is looking at formulating a policy for price control of patented drugs these discussions become important and an understanding and a background on how expensive drug discovery is. Also, the need to bring those drugs to the patients at an affordable price which is where drug discovery and affordability and treating patients has to be brought together